Oakland airport is first in U.S. to offer COVID-19 tests in a vending machine

 Travelers passing through Oakland International Airport during the pandemic can now pick up a COVID-19 test like they would a bag of chips or a pair of headphones.

For about $150, travelers can buy DIY saliva-sampling tests from vending machine kiosks in each terminal.

“We realized that travelers are going through a tough time right now, especially as we all navigate this COVID pandemic,” said Roberto Bernardo, the Oakland airport’s spokesman. “We wanted to give travelers another option for testing.”

Oakland International is the first in the U.S. to sell COVID-19 tests in vending machines, airport officials said.

https://ktla.com/news/california/oakland-airport-is-first-in-u-s-to-offer-covid-19-tests-in-a-vending-machine/

J&J and Novavax Data

 By Derek Lowe

Suddenly we have a lot more vaccine efficacy data to discuss! Yesterday came an announcement from Novavax about trials they’ve been conducting in the UK and in South Africa with their recombinant protein vaccine, and today comes equally anticipated data from J&J (Janssen) on their adenovirus vector candidate. We’ll have a look at the numbers in that order.

The full Novavax package should be coming out in a few days. But what we know now is that in the UK trial (roughly 15,000 people), the vaccine showed 89% efficacy. And the company says that around half of these participants were infected with the B.1.1.7 variant, so these are excellent results against that one and against “coronavirus classic”. The South African trial was smaller (around 4,000 patients), and the data have correspondingly more scatter in them. But the readout is clear: the vaccine is less effective against the B.1.351 variant, perhaps around 50%. Almost all the cases in this trial were from that one. Novavax says that they have already begun working on another protein vaccine to be used as a booster for those who’ve received another one, and that’s good news. Not least because Novavax also noted that they were seeing people infected with B.1.351 who had already been infected with the earlier strains. There appear to have been no significant safety signals during the trials (an initial report of volunteers being hospitalized appears to have been mistaken). Keep in mind that there’s another trial of the Novavax candidate still underway here in the US as well – the question is now how many countries will authorize the vaccine based on the data we have in hand and when this vaccine can be rolled out.

Now to J&J – then we’ll discuss some implications. Their data for the one-shot dosing protocol show 72% efficacy in the North American volunteers, 66% in Latin America, and 57% in South Africa. That last one has to be another B.1.351 effect. There were also no safety signals – adverse events were actually more frequent in the placebo group. There were also no real differences across different age groups, which is very good to see.

Now, these numbers from J&J are definitely lower than the Moderna and Pfizer/BioNTech vaccines. I wish that they were higher. But this is the landscape we have, and given the development timelines, I think we’d better get used to this it, because now the biggest and most advanced players have reported in. Broadly speaking, it looks like the mRNA vaccines have definitively higher efficacy, but we have to remember that their trials were run before the new variants got much of a foothold. We have in vitro data about how they might respond to B.1.1.7 and B.1.351, but so far we have no real-world efficacy reads. For all we know, the Moderna and Pfizer/BioNTech vaccines also come down to 50-60% efficacy against B.1.351.

But at any rate, with a 95% value (or the 96% seen with Novavax against “coronavirus classic”), you can have a good deal of confidence that you’re going to have solid real-world effects. When we see numbers like J&J’s, or (especially) AstraZeneca’s (the EMA says this morning that overall efficacy for that one is 60%), or probably everyone’s against B.1.351, we have to look more closely at the clinical outcomes. You may not be able to prevent so many people from going PCR-positive, but can you keep them out of the hospital? Out of the morgue?

J&J is saying that overall, their vaccine was overall at 66% efficacy at preventing all coronavirus infection, but 85% effective at preventing “severe disease” requiring hospitalization. They had a conference call this morning, and my impression is that this statement wasn’t clarified very much (we’ll hear more next week, I believe). But they also say that there were no coronavirus deaths at all in the vaccinated group. So the real-world effects are nothing to turn up one’s nose at – if this had been the first vaccine to report, we’d have been setting off fireworks. Similarly, it looks like the AstraZeneca/Oxford vaccine, for all the problems in figuring out its dosing and its efficacy numbers, also does a good job of preventing severe disease. We don’t have data on severity of disease from the Novavax team yet; I hope that we see it very soon.

Given the advent of the new variants – and the threat of seeing more of the same – all of these vaccines are going to have a part in beating back the pandemic. The AZ/Oxford, J&J, and Novavax vaccines do not have the ultra-cold-chain distribution problems that the mRNA vaccines have, and thus can have greater penetration into areas with less infrastructure. We also have to remember that these vaccines all have different manufacturing processes at many of their stages, which means that ramping them up doesn’t turn into a zero-sum cage match.

There are two more factors to consider. I keep coming back to the idea of antibody maturation via clonal selection of B cells, and I note that J&J says that the protection afforded by their vaccine did increase over time. That’s working in our favor with all the vaccines, but we have no idea (yet) if one of these might do a better job with this process than others. As far as I know, the only way to know is to keep collecting data to see if such differences emerge. The other thing to keep in mind is (as mentioned above) the possibility of retooling these agents to better deal with the new variants. My impression is that this would be easiest for the mRNA and recombinant protein vaccines (that is, for Moderna, Pfizer/BioNTech, and Pfizer) and harder for the viral-vector ones (J&J and AZ/Oxford). But we’ll need to clear up the regulatory framework on this – you’d think it should be much more like the clearance of (say) the yearly flu vaccine and not like coming in with a completely new vaccine.

It looks like we’re going to need these updates. The B.1.351 variant is clearly pushing the efficacy numbers down for the first crop of vaccines, and there is no reason whatsoever to think that the process will end there. We’ve got to stay ahead of the damn viruses however we can.

https://blogs.sciencemag.org/pipeline/archives/2021/01/29/jj-and-novavax-data

COVID Vaccine Effectiveness Falls Against South African Variant

 Pharmaceutical companies Pfizer and Novavax say their coronavirus vaccines work better against the coronavirus variant first found in the United Kingdom than the variant that apparently originated in South Africa.

Meanwhile, Novavax, whose vaccine is still in development, said it will start work on a new vaccine to target the South African variant. Pfizer, whose vaccine has been in wide circulation since December, said it doesn't think a new vaccine is necessary at this time.

The companies announced their testing results as the United States' first two cases of the South African variant were detected this week in South Carolina. The U.K. variant has been found in at least 26 states. Both variants appear to be more contagious than the original novel coronavirus.

A Pfizer news release said laboratory studies show its vaccine "elicits antibodies that neutralize SARS-CoV-2 with key mutations present in U.K. and South African variants."

The vaccine was "slightly" less effective against the South African variant, the news release said, but Pfizer and its European partner BioNTech "believe the small differences in viral neutralization observed in these studies are unlikely to lead to a significant reduction in the effectiveness of the vaccine."

Pfizer said it doesn't think a new kind of vaccine is necessary to battle the variants, but if there's evidence the variants are resistant to the vaccine, it will do so.

"Pfizer and BioNTech believe that the flexibility of BioNTech's proprietary mRNA vaccine platform is well suited to develop new vaccine variants if required," Pfizer said.

Novavax is one of the companies developing a COVID-19 vaccine under the government's Operation Warp Speed. It's vaccine is still in clinical trials and has not received emergency use authorization from the FDA.

In a Thursday news release, the company said its vaccine is 95.6% effective against the original coronavirus that swept the globe and 89.3% effective against the variant detected late last year in the United Kingdom.

But the Novavax vaccine was less effective against the South African vaccine. It only showed 60% effectiveness in study participants without HIV and 49.4% when HIV-positive participants were included in the study.

Still, that's good news, vaccine scientists said.

"The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally," Shabir Maddi, principal investigator in the Novavax COVID-19 vaccine trial in South Africa, said.

"This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa."

Novavax said it would start working on a vaccine to target the South African variant and will also develop a booster shot to work with the original vaccine.

The companies did not discuss how their vaccines will work against the variant that is surging in the Amazon region of Brazil. That variant was first detected in the United States this week.

In July, the U.S. government agreed to pay Novavax, a Maryland-based pharmaceutical company, $1.6 billion to produce 100 million doses of a coronavirus vaccine under Operation Warp Speed.

Both the Pfizer and Novavax vaccines are designed to work with two doses.

Modern said studies showed its vaccine, the second one now being used in the United States, is more effective against the UK variant than the South African variant.

Source

Pfizer. "IN VITRO STUDIES DEMONSTRATE PFIZER AND BIONTECH COVID-19 VACCINE ELICITS ANTIBODIES THAT NEUTRALIZE SARS-COV-2 WITH KEY MUTATIONS PRESENT IN U.K. AND SOUTH AFRICAN VARIANTS"

https://www.pfizer.com/news/press-release/press-release-detail/vitro-studies-demonstrate-pfizer-and-biontech-covid-19

Novavax. "Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial"

https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

https://www.medscape.com/viewarticle/944964

AstraZeneca COVID-19 vaccine applies for full regulatory approval in Brazil

 Brazilian health regulator Anvisa said on Friday that a COVID-19 vaccine developed by Oxford University and AstraZeneca Plc had applied for full regulatory approval.

The submission, the first of its kind in Brazil, was made by the federally funded Fiocruz Institute, which will manufacture the British vaccine locally. A spokeswoman for AstraZeneca confirmed the submission

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-REFILE-AstraZeneca-COVID-19-vaccine-applies-for-full-regulatory-approval-in-Brazil-32313769/

AstraZeneca says fixed most of European manufacturing issues

 AstraZeneca has fixed most of the issues affecting its European manufacturing and productivity at its plants there should start to increase, its chief executive said on Friday.

CEO Pascal Soriot said the company was focused on lifting production for the European Union after a public dispute over a shortfall in supplies in the first three months of the year.

“We believe we have fixed most of the issues,” Soriot told a news briefing, adding that productivity should improve rapidly over the coming months.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-plants/astrazeneca-says-fixed-most-of-european-manufacturing-issues-idUSKBN29Y2MD

Moderna COVID vaccines delay in Europe, elsewhere, adds to shortfalls

 Shortfalls in COVID-19 vaccine deliveries from U.S. drugmaker Moderna have spread across Europe, as Italy joined France and Switzerland in announcing the company’s shipments for February would miss expectations.

Moderna told Reuters it had revised short-term delivery guidance for Europe and elsewhere outside the United States based on the “ramp-up trajectory” at its drug substance supplier, which is Swiss contract drug manufacturer Lonza. The company said in normal circumstances the industrial launch of a vaccine could take three to four years to prepare.

Italy now expects Moderna to deliver 20% fewer vaccine doses than promised in the week starting on Feb. 7, Italy’s special commissioner for COVID-19 said on Friday, a day after neighbouring France and Switzerland announced similar shortfalls.

European countries are now grappling with broad vaccine delays, at least temporarily, as all Western vaccine makers with approved shots - Moderna, Pfizer and its German partner BioNtech, and AstraZeneca -- fall behind their initial delivery targets.

AstraZeneca and the European Union are already embroiled in a dispute over deliveries, while Pfizer said it needed to slow production at a Belgian plant in order to increase it in the long term.

“Minutes ago, Moderna told us about the cut. In the week beginning Feb. 7, only 132,000 doses will arrive, 20% less than agreed,” Italy’s Domenico Arcuri told a news conference, saying shortfalls from all suppliers had left Italy with 300,000 fewer shots than expected.

“Every day there is worse news than the day before. Vaccines are not soft drinks or snacks, they are the only antidote to the dark night that has lasted a year,” Arcuri said, adding decisions came unilaterally and without notice, and were “unacceptable”.

Moderna’s Europe-bound vaccine makes a long, complex journey from contract drug manufacturer Lonza in Switzerland to fill-and-finish facilities in Spain to a Belgian logistics centre, before it is shipped out.

“Moderna confirms that, as it scales manufacturing, it is on track to supply the next three months of deliveries and meet its Q1 and subsequent contractual commitments,” Moderna said.

“Moderna remains in close contact with all governments, recognising the importance of delivery planning for vaccination rollout.”

Lonza did not immediately comment on Friday. Lonza has previously said its Swiss plants will take “a couple of months” to reach “cruising speed.”

On Thursday, France said it expected 25% fewer doses of Moderna vaccines, just after Switzerland said Moderna would not meet its February target, jeopardising the country’s 1-million-vaccine-dose delivery target for the month.

Canada said it should receive 78% of the doses it had expected in a shipment due next week. [L1N2K428W]

Switzerland’s Federal Health Ministry did say it expected Moderna to make good on shortfalls in March, and that the company would reach its first-quarter targets.

Among Moderna’s confirmed global orders, the United States is due 200 million doses, the European Commission 160 million, Japan 50 million, Canada 40 million, South Korea 40 million, Switzerland 7.5 million, and Britain 17 million doses, with other markets including Israel, Qatar and Singapore also due vaccine, based on information from the company.

Moderna has committed to producing at least 600 million doses of its vaccine in 2021.

https://www.reuters.com/article/us-health-coronavirus-italy-vaccine/moderna-covid-vaccines-delayed-in-europe-and-elsewhere-adding-to-shortfalls-idUSKBN29Y1CD

UK says seeks urgent answers from EU over vaccine moves

 Britain said on Friday it was urgently seeking answers from the European Union over its decision to restrict the export of COVID-19 vaccines to Northern Ireland.

“The UK Government is urgently seeking an explanation from the European Commission about the statements issued by the EU today and assurances as to its intentions,” a spokesman for Prime Minister Boris Johnson said.

https://www.reuters.com/article/us-britain-eu-vaccines-statement/uk-says-seeks-urgent-answers-from-eu-over-vaccine-moves-idUSKBN29Y2WE